Regulatory Actions for Year 1993

Announcement of decision not to revise the maximum contaminant level goal (MCLG) for fluoride after consideration of recent reports concerning the health effects of fluoride.

NTP Information CitedNTP toxicology and carcinogenesis study of fluoride (TR-393) cited. Study concluded that there was equivocal evidence in male F344/N rats, and no evidence in female F344/N rats or male or female mice.

Establishment of a tolerance for the combined residues of the herbicide dicamba and its 5-hydroxy metabolite.

NTP Information CitedNegative results of NTP toxicology and carcinogenesis study of dichlorodibenzo-p-dioxin (TR-123) cited. The Agency has concluded that there is no potential carcinogenic risk to humans from a DCDD impurity in the dicamba to be used on cotton.

Proposed Rule: Proposed test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers and processors of five chemicals, acetophenone, phenol, n, n-dimethylaniline, ethyl acetate, and 2,6-dimethylphenol, to conduct testing for certain chemical fate, health and environmental effects.

NTP Information CitedThe proposed rule reflects EPA's current thinking in the area of mutagenicity testing, both as an endpoint and as it leads to oncogenicity testing. This new information is partially based on data from the NTP's study of the ability of short-term tests to predict carcinogenic potential. For phenol, no additional testing for developmental effects is being proposed because NTP studies are adequate for this endpoint. For N,N-dimethylaniline, the NTP toxicology and carcinogenesis study (TR-360) identified the rat as more sensitive than the mouse to the noncarcinogenic effects on erythrocytes and spleen.

Type: Final Rule

November 22, 1993

58 FR 61654

121-69-7

1993

EPA

Significant New Uses of Certain Acrylate Esters

Proposed a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for all acrylate esters falling within the definition proposed in this rule (acrylate substances).

NTP Information CitedThe EPA has concluded certain acrylates may present a risk of cancer. This conclusion is based primarily upon data available for a subset of acrylates which have demonstrated positive results. The NTP toxicology and carcinogenesis study of ethyl acrylate (TR-259) used to support conclusion.

Type: Proposed Rule

November 22, 1993

58 FR 61649

140-88-5

1993

EPA

Dichlorvos: Revocation of Food Additive Tolerance

Revocation of the food additive regulation for residues of the pesticide dichlorvos in or on packaged or bagged non perishable processed food.

NTP Information CitedData from the NTP toxicology and carcinogenesis study of dichlorvos (TR-342) in F344 rats showing statistically significant increases in leukemia in males at 2 dose levels was used.

Type: Final Rule

November 10, 1993

58 FR 59663

62-73-7

1993

EPA

Pesticide Tolerance for Dimethoate

Establishment of a tolerance for residues of the insecticide dimethoate in or on raw Brussels sprouts.

NTP Information CitedNTP concluded that dimethoate is a mutagenic compound based on its testing for gene mutation and chromosomal aberrations.

Revocation of certain food additive regulations for four pesticides, benomyl, mancozeb, phosmet, and trifluralin, which were included in a 1989 petition.

NTP Information CitedEthylene thiourea (ETU), a major contaminant, metabolite and breakdown product of mancozeb has been shown in the NTP toxicology and carcinogenesis study (TR-388) to induce cancer in animals.

Exemption from the requirement of a tolerance be established for residues of C.I. Pigment Violet #23, C.I. Pigment Blue #15, C.I. Pigment Green #7 and FD Red No. 40 when used as inert ingredients in pesticide formulations applied to growing crops only.

NTP Information CitedNTP data used to support the proposed tolerance exemptions for C.I. Pigment Blue #15 and C.I. Pigment Green #7. The NTP decided not to perform toxicology and carcinogenesis studies of C.I. Pigment Green #7 and C.I. Pigment Blue #15 based on the lack of absorption or adverse effects in a 90-day feed study in rats and mice.

Tentative Final Rule: Tentative affirmation that gelatin is generally recognized as safe (GRAS) for use as a direct human food ingredient.

NTP Information CitedData from the NTP toxicology and carcinogenesis study on penta­chloro­phenol (TR-349) showing PCP induces carcinogenic neoplasms in mice was used in modifying the regulation to state that there shall be no detectable levels of PCP in gelatin when tested by the method referenced in this regulation.

Establishment of a 3-year time-limited tolerance for residues of cryolite and/or synthetic cryolite.

NTP Information CitedData from the NTP toxicology and carcinogenesis study of sodium fluoride (TR-393) was considered in support of the tolerances.

Type: Final Rule

May 05, 1993

58 FR 26687

7681-49-4

1993

EPA

National Ambient Air Quality Standards For Ozone.

Announcement that revisions of the national ambient air quality standards for ozone are not appropriate at this time.

NTP Information CitedSubstantial new information has been published since the last criteria document. The NTP toxicology and carcinogenesis study on ozone (TR-440) to be peer-reviewed 11/93 was cited as an example of a study which may yield significant new information.